|Sanofi – Translate Bio Collaboration and License Agreement (As Amended)
“Pandemic” means an outbreak of a disease that occurs over a wide geographic area and affects a large proportion of people in such area.
“Pandemic Product” means a Product (i) which is indicated for the prevention of COVID19 for which a Pandemic has been declared by a Governmental Authority and (ii) for which the purchaser of such Product is a Governmental Authority that is purchasing the Product for the Pandemic, including but not limited to for stockpiling, emergency use, humanitarian donations and other circumstances, other than for sales in the ordinary course of business. A Product shall be deemed a Pandemic Product for so long as these two criteria are met.
Section 2.3.4 (Governance re Pandemic Products)
The Parties agree that the execution of the SARS-CoV-2 Collaboration Plan shall be carried out by their personnel having appropriate expertise and knowledge, however a JPT will not need to be formed for such activities. The Parties intend that the performance of their respective Collaboration activities directed to SARS-CoV-2 will not interfere or distract from the performance of the Collaboration activities directed to the other Licensed Fields or Technology and Process Transfer activities.
Section 3.2 (Collaboration Costs)
3.2.1 Collaboration Budget. As of the Second Amendment Execution Date, the Parties have agreed to Collaboration Budgets for each of Influenza, [**] and SARS-CoV-2 Licensed Fields and for Vaccine Platform Development, each of which are included in Schedule 1.11 (Collaboration Budgets). Within [**] of the Second Closing, the Parties shall (a) update the Collaboration Budget for the SARS-CoV-2 Licensed Field and Vaccine Platform Development, and (b) shall agree to initial Collaboration Budgets for each of the [**] Licensed Fields, which updated or initial Collaboration Budgets (as the case may be), when agreed by the Parties, shall form part of Schedule 1.11 (Collaboration Budgets) and shall be incorporated by reference herein. In the event that Sanofi elects in its sole discretion to extend the Collaboration Term pursuant to Section 2.2.2, the Parties may agree to additional Collaboration Budgets for up to three (3) additional Pathogens. The Parties shall update the Collaboration Budgets at least annually in accordance with Section 3.1.2.
3.2.2 Collaboration Costs. The estimated costs for Translate Bio’s Collaboration Activities will be as set forth in the applicable Collaboration Budget; provided, however, that Sanofi shall be responsible for paying FTE Costs, Out-of-Pocket Costs and Manufacturing Costs up to [**] percent ([**]%) of such estimated costs set forth in the applicable Collaboration Budget with respect to the Translate Bio Collaboration Activities. Any variation in excess of [**] percent ([**]%) of the Collaboration Budget will require Sanofi’s express prior written consent. Notwithstanding the first sentence of this Section 3.2, in no event shall Sanofi pay to Translate Bio an amount that is less than the amount of the FTE Costs set forth in the aggregate of all Collaboration Budgets for all Collaboration Plans, unless Sanofi terminates all Collaboration Plans.
4.1 Manufacturing Responsibility prior to Technology and Process Transfer
4.1.1 Unless otherwise agreed by the Parties in writing, Translate Bio shall be responsible for manufacturing and supplying non-clinical Products, related Materials (other than Licensed Materials provided under Section 3.9 or made by Sanofi as described in Section 3.9 or Section 6.4.2) and investigational Products, in each case, as required by and pursuant to the Collaboration Plan and Supply Agreement (as applicable):
(a) for each of the Influenza, [**] Licensed Fields, until the earlier of (1) the end of the first Phase 2 clinical trial for the first Product to Start a Phase 2 clinical trial on a Licensed Field-by-Licensed Field basis, or (2) [**] following execution of the Technology and Process Transfer Memorandum or Deemed Completion, as applicable, has occurred for each initial Licensed Field on a Licensed Field by Licensed Field basis; provided however that if [**] is combined with [**] into a Multi-Component Product, Translate Bio’s obligations in this paragraph (a) would include such Multi-Component Product but Translate Bio shall not have any obligation in respect of such a Multi-Component Product for any new order for Materials or Products after June 30, 2024; and
(b) for the SARS-CoV-2 Licensed Field, for non-clinical use and for all clinical trials required in such Licensed Field for orders placed no later than, the later of (i) the first Market Approval or (ii) June 30, 2025;
(c) for each of [**] Licensed Fields to the end of the first Phase I clinical trial for the first Product in such Licensed Field to Start a Phase I clinical trial; provided that Sanofi would not place any new orders for Materials or Products in the of [**] Licensed Fields after June 30, 2023.
(d) if the Collaboration Term is extended by Sanofi in its sole discretion in accordance with Section 2.2.2, for each of three (3) additional Licensed Fields (that is, such other Pathogens as Sanofi may select in its discretion), to the end of the first Phase I clinical trial for the first Product in such Licensed Field to Start Phase I; provided that Sanofi would not place any new orders for Materials or Products in such three (3) additional Licensed Fields after June 30, 2024.
Notwithstanding Section 4.7.8 (Deemed Completion), Translate Bio shall be responsible for manufacturing and supplying non-clinical Products, related Materials (other than Licensed Materials provided under Section 3.9 or made by Sanofi as described in Section 3.9 or Section 6.4.2) and investigational Products, in each case, as required by and pursuant to the Collaboration Plan and Supply Agreement (as applicable) for each of the [**] Licensed Fields referred to in paragraph (c) above during the period set forth in paragraph (c) and also, if Sanofi elects to exercise its Collaboration Term Extension, an additional three (3) Licensed Fields referred to in paragraph (d) above during the period set forth in paragraph (d) above, even if Sanofi is also manufacturing Products in such Licensed Fields.
The Parties will monitor Sanofi’s demand for investigational Products so that Translate Bio will be able to meet Sanofi’s requirements without interference with Translate Bio’s other programs, including advanced planning, reservation of suites and employee allocations.
4.1.2 As part of its manufacturing obligations pursuant to this Section 4.1, Translate Bio will also be responsible for generating all CMC data for Products in the Licensed Fields and for providing to Sanofi the applicable manufacturing related modules of all Regulatory Filings, including all required supporting cGMP and analytical data documents, for integration into the Regulatory Filings by Sanofi, in each case, as required by and pursuant to the Collaboration Plan and the Supply Agreement and at Sanofi’s expense.
4.4.3 SARS-CoV-2 Commercial Supply Agreement. The Parties shall negotiate in good faith and execute a supply agreement (the “SARS-CoV-2 Commercial Supply Agreement”) and a related quality agreement (the “SARS-CoV-2 Quality Agreement”), each such agreement shall be consistent with industry standards, governing the terms of the supply of Phase III and commercial supply of Products in the SARS-CoV-2 Licensed Field by Translate Bio by no later than December 31, 2020. The terms of the SARS-CoV-2 Commercial Supply Agreement shall include a [**] percent mark-up to be added to Translate Bio’s Manufacturing Costs. Concurrent with the execution of the SARS-CoV-2 Supply Agreement, the Parties shall execute a separate Pharmacovigilance Agreement or amend any existing Pharmacovigilance Agreement as necessary with respect to the SARS-CoV-2 Licensed Field.
Section 4.10 Technology Transfer: SARS-CoV-2
4.10.1 SARS-CoV-2 Technology and Process Transfer Plan. Translate Bio and Sanofi will establish a plan for the transfer of Licensed Technology required for the development and manufacturing of Products in the SARS-CoV-2 Licensed Field at [**] scale for each of the mRNA, LNP and formulated drug substance, consistent with Schedule 4.10.1 (the “SARS-CoV-2 Technology and Process Transfer Plan”). Translate Bio shall use Commercially Reasonable Efforts to deliver to Sanofi the tangible items of the Licensed Technology listed within the SARS-CoV-2 Technology and Process Transfer Plan within the timeframes prescribed therein. When such SARS-CoV-2 Technology and Process Transfer Plan is agreed by both Parties, it shall be incorporated herein by reference.”
4.10.2 Timing. The Parties will commence performance of activities described in the SARS-CoV-2 Technology and Process Transfer Plan upon the payment of the first milestone in accordance with Section 7.4.1(b); provided however that if such milestone is not then due and has not been paid, Sanofi may elect, in its discretion, to pay the SARS-CoV-2 Technology and Process Transfer Commencement Fee (defined below in Section 7.3.2) by delivering to Translate Bio notice of such election; further provided however that if the first milestone in accordance with Section 7.4.1(b) is achieved after Sanofi has paid the SARS-CoV-2 Technology and Process Transfer Commencement Fee, then the amount of such SARS-CoV-2 Technology and Process Transfer Commencement Fee shall be fully credited against such milestone payment.
4.10.3 Technology and Process Transfer Lead. The Parties shall each appoint a technology and process transfer lead to oversee and manage the technical transfer process in accordance with SARS-CoV-2 Technology and Process Transfer Plan.
4.10.4 Success Criteria/ SARS-CoV-2 Technology and Process Transfer Memorandum. Within [**] following successful completion of the SARS-CoV-2 Technology and Process Transfer Plan in accordance with the Success Criteria listed in the SARS-CoV-2 Technology and Process Transfer Plan, the Parties shall execute a SARS-CoV-2 Technology and Process Transfer Memorandum, a form of which SARS-CoV-2 Technology and Process Transfer memorandum is attached hereto as Schedule 4.10.4 (the “SARS-CoV-2 Technology and Process Transfer Memorandum”).
4.10.5 Qualified Personnel. Each Party will make their respective suitably qualified and experienced employees available (whether, as reasonably necessary, by telephone, e-mail, in person or such other method as the Parties may find mutually convenient) to execute the SARS-CoV-2 Technology and Process Transfer in accordance with SARS-CoV-2 Technology and Process Transfer Plan. Translate Bio’s personnel or its CMOs that are transferring SARS-CoV-2 Licensed Technology under the SARS-CoV-2 Technology and Process Transfer Plan shall have actual knowledge of the Licensed Technology and Licensed Improvements, if any, they are transferring. The SARS-CoV-2 Technology and Process Transfer may include on-site training at Translate Bio’s or its CMO’s facilities and also at Sanofi’s facilities as per the SARS-CoV-2 Technology and Process Transfer Plan. Translate Bio shall use commercially reasonable efforts to ensure that it has contracts in place with its CMOs necessary to complete any action in respect of the SARS-CoV-2 Technology and Process Transfer Plan that requires the cooperation or participation of such CMO so as to not delay the execution of such SARS-CoV-2 Technology and Process Transfer Plan.
4.10.6 Third Parties. In the event that Sanofi or Translate Bio need to retain any Third Party to assist with any aspect of executing the SARS-CoV-2 Technology and Process Transfer Plan, Sanofi or Translate Bio (as the case may be) shall execute an agreement with each such Third Party to protect the other Party’s Confidential Information the terms of which will be consistent with this Agreement.
4.10.7 Costs. Sanofi shall bear all costs and expenses associated with the execution of the SARS-CoV-2 Technology and Process Transfer Plan. A budget for the cost of executing the SARS-CoV-2 Technology and Process Transfer Plan shall be established by the Parties, and mutually agreed by the Parties as part of such plan. In the event that Sanofi and Translate Bio perform technology transfer by Sanofi observing Translate Bio’s CMO manufacturing of Product, and such Product will be supplied to Sanofi under this Agreement or a Supply Agreement, then Sanofi shall only pay the additional costs incurred by Translate Bio and such CMO for such technology transfer which are not otherwise already paid to Translate Bio pursuant to this Agreement or any Supply Agreement.
4.10.8 Technical Assistance. Upon execution of the SARS-CoV-2 Technology and Process Transfer Memorandum referred to in Section 4.10.4, and for a period of [**] thereafter, Translate Bio shall use Commercially Reasonable Efforts to provide reasonable assistance to Sanofi in connection with manufacturing of Products in the SARS-CoV-2 Licensed Field, at Sanofi’s expense, and upon Sanofi’s reasonable request.
Section 7.1 (Collaboration Funding)
7.1.1 Collaboration Funding. In consideration of the performance by Translate Bio of the Translate Bio Collaboration Activities in the Collaboration, Sanofi shall pay Translate Bio the agreed sum set out in the Collaboration Budget for each of (a) FTE Costs, (b) Out-Of-Pocket Costs, and (c) Manufacturing Costs. Each of FTE Costs, Out-Of-Pocket Costs or Manufacturing Costs is a “Cost Category”, which shall be accounted for separately by Translate Bio and in no event shall Translate Bio include costs or expenses from one such Cost Category in another such Cost Category. In the event that the Collaboration Budget or Supply Agreement includes certain Out-of-Pocket Costs or Manufacturing Costs which Translate Bio is [**], Sanofi shall [**] the full amount of those Out-of-Pocket Costs and Manufacturing Costs to Translate Bio.
7.1.2 External Funding. The Parties shall discuss and coordinate efforts during the Collaboration Term (and any extension thereto) to seek and obtain funding which may be available from time to time to support the research, development, manufacture and commercialization of Products in the SARS-CoV-2 Licensed Field from Third Party organizations, including any governmental or non-governmental organization such as the United States Biomedical Advanced Research and Development Authority (BARDA) and the Coalition for Epidemic Preparedness Innovations (CEPI); provided however that no Party shall agree to accept any funding on behalf of the other Party without such Party’s express prior consent, and further provided that no Party shall be obligated to seek or accept the funding of any such Third Party. Any dispute under this Section 7.1.2 shall be resolved by referring the matter to the JSC.
7.3.2 SARS-CoV-2 Technology and Process Transfer Commencement Fee. In the event that Sanofi delivers notice of its election to proceed with the execution of the SARS-CoV-2 Technology and Process Transfer Plan in accordance with Section 4.10.2, Sanofi shall pay Translate Bio a non-refundable, non-creditable (except as set forth in Section 4.10.2) fee of [**] dollars ($[**]) (the “SARS-CoV-2 Technology and Process Transfer Commencement Fee”) within [**] after receiving all of the following (i) Translate Bio’s invoice, (ii) Translate Bio’s wire transfer information required to process the payment and (iii) Translate Bio’s residency forms; provided however that Translate Bio may not issue any invoice under this Section 7.3.2 (SARS-CoV-2 Technology and Process Transfer Commencement Fee) until Translate Bio receives Sanofi’s notice in accordance with Section 4.10.2.
Economic Terms for Pandemic Products (First Amendment, superseded by the Second Amendment, see below):
Economic Terms for Pandemic Products (Second Amendments):
Section 13.10 (Press Release)
Translate Bio and/or Sanofi may announce the inclusion of SARS-CoV-2 as a Licensed Field in the Agreement in a press release in the form attached hereto as Schedule 13.10.1 (SARS-CoV-2 Press Releases). In addition, Translate Bio and/or Sanofi may issue additional press releases concerning their Collaboration activities directed to SARS-CoV-2, provided that a draft of any such press release shall be delivered to the other Party at least [**] in advance, and the receiving Party shall not unreasonably withhold its consent to the issuance of such press release. Notwithstanding the foregoing, any Party may issue a press release regarding their respective Collaboration activities directed to SARS- CoV-2 if such disclosure is required by applicable Law or the rules of the US Securities and Exchange Commission (SEC) or any securities exchange, as reasonably advised by the disclosing Party’s counsel.
Section 13.11.4 (Publication related to the Pandemic Products)
Notwithstanding Section 13.11,1 and 13.11.2, the Parties recognize the importance of contributing to the field of SARS-CoV-2 research rapidly and therefore the Parties have agreed to use the following expedited review process with respect to any proposed Publication of results arising from their SARS-CoV-2 Collaboration Activities. A Party wishing to submit a Publication shall provide the other Party with a draft of such Publication at least [**] in advance of the planned date of submission to enable the other Party to consider its impact on its business. A Party that receives a draft Publication from the other Party under this Section 13.11.4 shall not unreasonably withhold its consent to the submission of the Publication.
Sections 16.6.3 & 16.6.4 (Termination for Material Breach in Relation to Pandemic Products)
16.6.3 Notwithstanding Sections 16.6.1 or 16.6.2, if (i) despite good faith negotiations, the Parties are unable to mutually agree in a separate amendment to their respective commitments and responsibilities to conduct activities directed to clinical development and commercialization of a Product directed to SARS-CoV-2, or (ii) Sanofi is in breach of its material obligations with regard to Collaboration activities solely directed to SARS-CoV-2, Translate Bio shall have the right to terminate and revoke the license granted herein solely with respect to the Licensed Field of SARS-CoV-2 on sixty (60) days written notice to Sanofi. Upon such termination and revocation by Translate Bio, (i) the Licensed Field of SARS-CoV-2 shall cease to be a Licensed Field and shall be a Translate Bio Field and (ii) the Parties shall negotiate in good faith a termination agreement with respect to Translate Bio’s use of any Sanofi Collaboration Technology or jointly-owned Collaboration Technology, that is necessary or useful to the further development or commercialization of a Product directed to SARS-Co-V-2.
16.6.4 Notwithstanding Section 16.6.1 or 16.6.2 or 16.6.3, Translate Bio shall not have the right to terminate Sanofi’s rights granted herein with respect to any Licensed Field other than SARS-Cov-2 in the event of a material breach by Sanofi of its material obligations with regard to SARS-Cov-2.